# FDA 483 - Dr. Louis R. Manara - May 23, 2023

Source: https://www.globalkeysolutions.net/records/483/dr-louis-r-manara/8c235da5-67b9-4acf-8070-bf86fa707e21

> FDA 483 for Dr. Louis R. Manara on May 23, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Louis R. Manara
- Inspection Date: 2023-05-23
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Dr. Louis R. Manara, Practice Owner, in Voorhees, NJ, from May 16-23, 2023, identified one observation. The firm failed to determine donors ineligible despite the presence of risk factors for communicable disease agents. Specifically, five directed semen donors with risk factors, including men who have had sex with another man in the preceding 5 years, were deemed eligible.

## Related Documents

- [483 - 2020-01-28](https://www.globalkeysolutions.net/records/483/dr-louis-r-manara/eae1e173-e57f-4b3e-ac12-4f8b4ea571cd)
- [483 - 2021-10-21](https://www.globalkeysolutions.net/records/483/dr-louis-r-manara/3b7ec250-afbe-4f93-b4ab-cd35e325cafb)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)

Company: https://www.globalkeysolutions.net/companies/dr-louis-r-manara/4b0cc23b-4140-4404-b357-4c5e1351800b

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248